has become the go-to source for comments on how drug companies have been using ghostwriters to inject marketing messages into the medical literature, a controversy that prompted powerful Sen. Charles Grassley, R-Iowa, to send on Aug. 11 to the National Institutes of Health asking, among other things, "What is the current NIH policy on ghostwriting with regards to NIH researchers?"

The force behind the project, which tries to give doctors continuing medical education that is free from industry influence, Fugh-Berman has been the . An Associate Professor in the Complementary and Alternative Medicine Master's program in the Department of Physiology and Biophysics, Fugh-Berman is an expert witness for the plaintiffs in a lawsuit brought by patients against Wyeth over the adverse effects of hormone replacement therapy drugs.

I reached her at her office at the Georgetown University Medical Center. I posted the of our conversation last Friday. The second part is below. It has been edited for space and clarity.

Q: Are there journals that you know of that have taken a hard stance against conflicts of interest?

A: and have taken strong stances against ghostwriting. has the best conflict of interest requirements. They have very specific questions to try to find out whether there has been any outside influence. If you just say to an author, "Disclose relevant conflicts of interest," nobody thinks they have any relevant conflicts of interest. To them it's like, "You don't trust me?"

Physicians may not even know that their conflicts of interest are relevant to the article they are writing. Say I'm an researcher and this company is giving me money for my research. I might not know that they're developing a drug related directly to my work. American Family Physician has this long form that they make researchers fill out. They ask questions such as "Did anyone provide any editorial assistance or manuscript preparation? Was there anyone who provided substantial assistance whose name is not on the paper as an author?" So you would really have to lie. And it doesn't leave much room for interpretation. The more room you leave for interpretation, the less accurate answer you're going to get.

The Journal of General Internal Medicine did a great job of trying to clamp down, including interviewing authors. and are wonderful co-editors of that journal. Martha told me about speaking with an author who did not understand that it was an issue that a medical education company had helped out in writing the article.

Q: Isn't that a beautiful euphemism, "medical education company"? How long have these things been around?

A: Good question. I'm not sure. I'm guessing at least 30 years.

Q: What's your sense of how large the industry is?

A: There are more than 500 of these companies. Some specialize more in meetings and events and others more in writing support. Some do both. A lot of them do continuing medical education work.

Q: Who are their biggest customers?

A: The majority of their money comes from manufacturers of FDA approved products.

Q: What would be a legitimate reason for a researcher to work with a Medical Education Company?

A: They're really good at generating pretty slides and making hotel reservations and figuring out the catering. So if a government agency wanted to hire an MEC to put on a conference that would be a good use. As far as writing, I think that medical writers should be hired by government agencies and universities to make manuscripts intelligible. There's nothing wrong with hiring good writers. If you're not a good writer, please hire a writer, by all means. But the writing should reflect the opinions of the authors, and the people who did the writing
should be acknowledged.

Q: What would you do if you asked me to put together the first draft of an article that you later submitted for publication?

A: I would put you on as a co-author. At a minimum someone should be acknowledged as giving writing assistance. But if you wrote the first draft, then that's beyond editorial assistance. That person should be an author. People aren't put on as authors, though, and their affiliations
aren't explained. What's so bad about the ghostwriting in the medical literature is that the opinions and messages are those of the industry, not the authors. That's scary, because the literature has been corrupted. The literature is something that clinicians depend on to make decisions that affect patients.

Q: These aren't fresh-out-of-college physicians and scientists authoring these ghostwritten papers. These are university professors, associate deans, people with long lists of publications. Why would someone risk their reputation by signing a journal article they did not write?

A: They don't risk their reputation. In the medical profession, it's common enough that it is accepted. When I was a ghostwriting company, all I had to do was sign that form and say, "Great. No changes," and I get a publication to my credit. A single-authored publication, which looks good. I don't get paid. But I get a single-authored publication on my CV.

Q: The from authors when they are caught working with a ghostwriter seems to be just what you said, "It's common, and it's accepted." They also say, "These are my ideas, even though I didn't write them." Isn't it possible that they simply see their ideas synthesized and written in a compelling way and so they sign on?

A: It is funny to hear physicians say, "I agreed with what was in there." Look, I agree with that doesn't make me an author. I have to say, physicians are capable of a high degree of naiveté. I know it seems strange to say that, but I can tell you that they are. There are so many physicians that say, "Yes, I'm being paid by a pharmaceutical company, but I'm not changing anything I say. They don't tell me what to say. They are flying me around the world and putting me up in hotels but I am saying what I believe." That may be true. However, you need to understand that you have been selected because what you are saying backs up their marketing message. Does that trouble you at all?

Q: With PharmedOut, you've had the opportunity to talk with a lot of physicians face to face about their work with drug companies.

A: We have talked to a lot of physicians at grand rounds sessions. We have a lot of industry insiders, people who do work with industry and who used to, who have talked with us. One of our high-up industry insiders told me their job is to help identify up and coming faculty members. Academic faculty who are getting published or are bright young researchers. They fly out and take them to dinner with a nice bottle of wine, just to listen to them. If what the young faculty member is saying is consistent with the marketing goals that the company has, they will be groomed. They will be flattered and hired to do various things. "Your work is so important for public health, and we want to help you get that out there." They will fly them around and get them money for their research.

These researchers don't seem to understand that if they start to express doubts about a previous position or something that is not in line with a marketing message, they will be dropped like a hot potato. There was a piece in the New York Times Magazine, "," by Dr. Daniel Carlat. He did some work for Wyeth. And when he started to stray from the company line, he was ed by someone from the company who said, "We heard you were not as enthusiastic about our drug as you had been in the past. Are you feeling well?"

Q: It is easy to mock the drug companies and they are big corporate overlords who are scheming behind the scenes. But to be fair, aren't they groups of researchers, too, working on products that will have and have had huge public health benefits? At the same time, they know that their work won't be taken as seriously without allying with an independent voice of some sort.

A: This isn't about research. This is about marketing. Yes, the drug companies are very good at what they do. What I tell physicians is that we have a fiduciary responsibility to our patients and drug companies have a fiduciary responsibility, a legal obligation, to their shareholders. Those obligations aren't similar. The concept that physicians and pharma are partners is very widely believed, and has been the case for more than 100 years. That doesn't make it good for patients. What other profession expects to have free lunch, for example? But we do expect free lunch because we start to get free lunch in med school and then it continues in residency and then we expect it when we start or first job. That's your normality.

Q: When did you first decide that this might seem normal, but it wasn't the kind of normal you wanted?

A: In medical school, although I certainly ate my share of drug company food. I was appalled when I went to a required lecture and the first 10 minutes was a drug rep making a sales pitch. I told a professor later that I wasn't going to listen to sales pitches. I wasn't paying $28,000 a year to go to hear advertising.

Q: What was the professor's response?

A: I was told if I didn't go to these talks, I would be failed. That's how it worked then and works now. The drug companies usually give the residency coordinator a list of suggested speakers, and you are not required to choose one but you will choose one from the list because they are paying for lunch for all of your medical students and they are flying in people from all over the country. Also, you recognize the names of the people on the list. They are top medical professionals. And you want to expose your students to these people.

Q: How can we as health writers do a better job revealing the names of the researchers who have worked with ghostwriters?

A: The names are on a lot of these documents that were , so that's going to be fun. You can ask any research scientist that you interview about conflicts in detail. Don't just ask, "Do you have any conflicts of interest?" Ask, "What relationships do
you have with industry, including consulting, being part of a speakers bureau, working on funded research?" Give them a whole list. And then, use sources that don't have conflicts. That would be even more important. You know , right? He talks a lot about this. Shannon Brownlee and Jeanne Lenzer created a list of . And it drove pharma bats because the prevailing line is that all experts have conflicts. They say anyone who knows anything must have an industry connection. And, it is true that the ones who are most prominent are the ones with connections to industry because they are flown around and have book chapters written for them and articles published for them. They have their articles handed out by drug reps, mailed to physicians and highlighted in other ways. But there are people who aren't conflicted who have done great work that does not have any industry influence.

Q: We talked about the company that approached you to sign a ghostwritten article. How could we trace back articles in that same vein? How could we find all the articles on warfarin that have embedded marketing messages and trace them back to AstraZeneca?

A: People would have to be trained to recognize these marketing messages. It could be done. We do it here. It would help to have a marketing or advertising background. Writers do have a foot up on this, because I think it would be easier for them to identify insincere writing. If you know any reporters who want to work on this, I have a ton of things they could work on. We're sort of inventing methodologies of looking at biases in continuing education in review articles. We've been really successful at getting to doctors and subscribers and have created documents that really work. We've submitted a manuscript called "Why Lunch Matters," which is about the responses we got after our grand rounds. It was so moving what physicians were writing under the comments section. "I'm never seeing drug reps again." "I'm not going to industry funded dinners." "I won't take samples anymore." And we weren't even telling them not to do that. But we were showing them information in the marketing literature about how drug companies really view them.

It's been very inspiring work to do because it's been great to see how physicians will respond appropriately when they are given information about marketing practices. Nobody thinks that they are affected by advertising. In our talks, and our web-based CME (continuing medical education) course "The Pharmalyzer: Are you prescribing under the influence?" We provide a lot of images from ads without the brand names of the drugs, and we ask, "What drug does this represent?" They all know them. Then we ask them to give the generic names for a bunch of these same drugs, and they can't do it. This is not a coincidence.

Q: I'm thinking about other ways to unmask some of this ghostwriting. Do you think some people are so craven they might have entire CVs made up of these ghostwritten articles? Could you take a physician's CV and just go through it article by article looking for industry influence?

A: Yes. Have you heard the term "pharma whore"? Physicians say it is someone who takes a lot of drug company money. But the pharmaceutical industry uses it for someone who will say anything for money but has no loyalty to a specific company. They are sometimes useful, but the companies don't trust them. They could pay someone to say something they want them to say, but the next week they will say something for their competitor.

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